Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

NCT01106976 | Completed Results

• 1 other identifier: E7285-R
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.

Conditions

Parkinson's Disease

Keywords

PET; acetylcholine

Outcome Measures

Primary Outcomes (1)

• AChE PET Neuroimaging

  AChE PMP PET hydrolysis rate outcome measure. AChE \[11C\]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.

  4 yr

Study Arms (1)

Group 1 Parkinson disease subjects

Subjects with Parkinson disease who previously participate in a motor and brain PET (brain positron emission tomography) imaging study who were invited for a longitudinal observational study.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruited in previous study

You may qualify if:

• Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria for PD.
• Hoehn and Yahr stages 1-2.5 at initial recruitment in baseline study.
• Absence of dementia confirmed by neuropsychological testing at initial recruitment in baseline study.

You may not qualify if:

• contra-indication for magnetic resonance study
• Pregnancy or breastfeeding

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Michigan: collaborator

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (3)

• Bohnen NI, Frey KA, Studenski S, Kotagal V, Koeppe RA, Scott PJ, Albin RL, Muller ML. Gait speed in Parkinson disease correlates with cholinergic degeneration. Neurology. 2013 Oct 29;81(18):1611-6. doi: 10.1212/WNL.0b013e3182a9f558. Epub 2013 Sep 27.

  PMID: 24078735 RESULT

• Muller ML, Albin RL, Kotagal V, Koeppe RA, Scott PJ, Frey KA, Bohnen NI. Thalamic cholinergic innervation and postural sensory integration function in Parkinson's disease. Brain. 2013 Nov;136(Pt 11):3282-9. doi: 10.1093/brain/awt247. Epub 2013 Sep 20.

  PMID: 24056537 RESULT

• Kotagal V, Albin RL, Muller ML, Koeppe RA, Frey KA, Bohnen NI. Diabetes is associated with postural instability and gait difficulty in Parkinson disease. Parkinsonism Relat Disord. 2013 May;19(5):522-6. doi: 10.1016/j.parkreldis.2013.01.016. Epub 2013 Feb 23.

  PMID: 23462483 RESULT

Biospecimen

Retention: NONE RETAINED

Saliva

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Observational study.

Results Point of Contact

• Title: Nicolaas Bohnen
• Organization: VAAAHS

Nicolaas.Bohnen@va.gov

7349988400

Study Officials

• Nicolaas I Bohnen, MD PhD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 20, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: February 1, 2016
• Results First Posted: February 1, 2016

Record last verified: 2015-12

Locations

US (1)